Patients undergoing partial hepatic resection for various underlying diseases. MedDRA version: 21.1 Level: LLT Classification code 10077348 Term: Liver resection System Organ Class: 100000004865
Conditions
Interventions
Trade Name: BOTOX
Pharmaceutical Form: Powder for injection
INN or Proposed INN: Clostridium botulinum Toxin Typ A
CAS Number: 93384-43-1
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration u
Sponsors
University Hospital Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria – Patients scheduled for elective, primary hepatic resection with no planned biliary reconstruction – Male or female patients =18 years of age – Ability of patient to understand character and individual consequences of the clinical trial – Written informed consent (available before enrollment) – For women with childbearing potential, presence of negative urine or blood pregnancy test, and adequate contraception until 14 days after trial intervention Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: – Patients who already underwent papillotomy for any reason or have an inlaying bile stent – Serious cardiovascular disease (e.g. myocardial infarction in the last 12 months, congestive heart failure NYHA III/IV, unstable angina pectoris) – Serious renal insufficiency, i.e. creatinine clearance III – Hypersensitivity to any BTX preparation or to any of the components in the formulation – Neuromuscular disorder, e.g. peripheral motor neuropathic disease, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome), or any other neurological disorder with associated increased risk for the patient undergoing BTX injection – Any condition in which duodenoscopy and/or the trial intervention is not possible, e.g. for anatomical reasons, or obsolete in the actual situation, e.g. in patients with acute pancreatitis – History of BTX application – Understanding or language problems – Inability to comply with study and/or follow-up procedures – Pregnancy or lactation – Concurrent participation in another interventional clinical trial – Any condition or situation which could result in an undue risk for the patient and/or influence outcome measures in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The PREBOT II trial is a multicentre, randomised controlled phase II clinical trial with two parallel study arms. The primary objective of this pilot trial is to investigate the benefit of an endoscopic injection of botulinum toxin into the sphincter Oddi prior to planned partial liver resection to reduce postoperative bile leakage. The main focus is on testing the safety and feasibility of the procedure, but first data on its effectiveness will also be gained.;Secondary Objective: The secondary objectives are to evaluate clinically relevant postinterventional and postoperative complications in intervention and control group: Severity of bile leakage according to the ISGLS, occurrence of post-interventional pancreatitis, post-hepatectomy liver failure according to the ISGLS, postoperative overall morbidity ( including post-hepatectomy hemorrhage according to the ISGLS, intra-abdominal fluid collection/abscess, perioperative sepsis, etc.) and severity of listed postoperative complications according to the Clavien-Dindo classification, reinterventions/-operations, mortality, quality of life using the Short Form (SF)-12 Health Survey, intensive/intermediate care unit stay, total hospital stay, readmission to hospital ;Primary end point(s): Occurrence of postoperative bile leakage within 30 days after hepatic resection according to the definition of the International Study Group of Liver Surgery (ISGLS).;Timepoint(s) of evaluation of this end point: Visit 4: (3 days after operation) POD = post-operative day Visit 5: (day of hospital discharge) Visit 6: POD 30 Visit 7: 3 months after index operation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Severity of bile leakage according to the ISGLS, occurrence of post-interventional pancreatitis, post-hepatectomy liver failure according to the ISGLS, postoperative overall morbidity ( including post-hepatectomy hemorrhage according to the ISGLS, intra-abdominal fluid collection/abscess, perioperative sepsis, etc.) and severity of listed postoperative complications according to the Clavien-Dindo classification, reinterventions/-operations, mortality, quality of life using the Short Form (SF)-12 Health Survey, intensive/intermediate care unit stay, total hospital stay, readmission to hospital;Timepoint(s) of evaluation of this end point: Secondary endpoints are assessed during study visits on postoperative day (POD) 3, day of discharge, POD 30 and 3 months after the index operation. | — |
Countries
Germany
Contacts
Public ContactSDGC
Study Center of the German Surgical Society (SDGC)
Outcome results
None listed